Transcription

• Speaker #0

  In recent years, I have recorded numerous conversations about innovation in healthcare, but looking back, some of them now take on a different dimension. Because behind scientific advances, we discover something else. National strategies, choices in industry and political balances. The United States is investing massively. China is accelerating. Europe is searching for its path. Innovation is not only scientific, it is also geopolitical. In this mini-series, I offer you an editorial reinterpretation of several episodes already published on PharmaMinds to explore a simple question, who really controls innovation? If these topics interest you, I invite you to subscribe to follow the entire series. And of course, I would be very curious to read your reactions and experiences in the comments. Europe versus the United States versus China. Who will lead genomic medicine? Genomic medicine is no longer theoretical. The United States is investing massively, China is deploying on a large scale, and in Europe, projects like PERIGENOMED are seeking to redefine newborn screening. An investment phase for the project has been approved, with 20,000 babies to be screened and 15 maternity wards involved. Research is progressing, but the real question goes beyond science. Each world region is making progress with its own ethical framework. its own regulatory framework, its own societal limitations. The question then becomes a strategic one. Who will set the rules for preventive genomic medicine? If you want to follow the entire series, consider subscribing.

• Speaker #1

  At the beginning of my career, I had a difficult experience. I became acquainted with a family whose eldest daughter, who was six years old, had just been diagnosed with metachromatic leukodystrophy. These are children who begin to lose their vision and hearing, can no longer walk and eventually pass away. The parents of this little girl came in for a consultation to screen the younger sister. Unfortunately, the younger sister was also affected and both little girls passed away. And at the time, I thought it was extremely unfair and that to put a stop to this, we needed to be able to make diagnoses much earlier and also have a treatment. And now this disease is treated with gene therapy. The PERIGENOMED project is widely recognized as the leading national pilot project on this issue.

• Speaker #0

  The stakes are clear.

• Speaker #1

  There is a general diagnostic tool, which is known as genome sequencing. A single test could potentially allow us to screen for several hundred different diseases. And will France decide to embark on this specific policy or not, when compared to the other available options?

• Speaker #0

  Hello everyone, welcome to this new episode of PharmaMinds. This episode was produced with the support of Kyowa Kirin. Today I'm absolutely delighted to be here in the city of Dijon to extend a very warm welcome to our guest, Professor Laurence Fevre, who is a highly renowned and leading expert in the field of genetics. Hello Laurence.

• Speaker #1

  Hello Nathalie, I am happy to be here as well.

• Speaker #0

  For the very first time in our series, we are going to dive deep into the world of genetics today. This is a topic that some might consider to be a bit niche, and you might even think it is a complex subject meant for experts that does not really concern everyone. But the real reason I am standing here today is to tell you that, in fact, we are at a pivotal moment right now. because we are currently talking about the field of advanced genomics as it is applied to proactive preventive medicine. We are talking about medicine that is no longer solely about curing, but about taking care of a disease, almost before it emerges, before it even manifests. And it's this specific subject matter that I find truly fascinating today. What's particularly fascinating is to approach it from the unique angle of genomics. which raises a wide range of significant and complex questions, technological, ethical and profound economic considerations. So I'm delighted to be able to have this conversation today. One project that is particularly emblematic and that you are currently working on today is the Paris Genomed project. This is a highly significant and major initiative of truly national scope and very great importance. Let's get started.

• Speaker #1

  Let's get started.

• Speaker #0

  We can begin our discussion with this PERIGENOMED project, which is essentially defined as an innovative newborn screening project. I'll let you tell me about it.

• Speaker #1

  Yes, so newborn screening is something that has existed for a very long time, since it was implemented in France in 1972, around a disease called phenylketonuria, which is a rare disease, not very well known, because it no longer exists in France, ultimately. This condition caused what is known as a metabolic disorder, resulting from a significant deficiency of a critical enzyme that ultimately led to a very severe intellectual disability. And it was shown quite early on that if a special diet was given from birth to children who had this disease, the disease would not develop. So The process of newborn screening for newborns was launched in many countries, in all countries that had the capacity to implement it. And over time, several other diseases were added, with the number of diseases differing significantly, depending on the specific country. In France currently, we screen for a total of 13 different genetic diseases, plus hearing loss. And this year, three additional new groups of diseases are going to be added to the program.

• Speaker #0

  And so the challenge is maybe there are, from memory, 5,000 diseases that are genetic?

• Speaker #1

  Yes, we are talking about several hundred conditions. And the primary challenge we face is indeed to demonstrate that by utilizing a general-purpose tool, which is genome sequencing, a single comprehensive test could allow us to screen for several hundred genetic diseases. Currently, we have a list of diseases that are considered treatable. There are a little over 400. and others that are considered actionable, of which there are also a little over 400, and these will be optional. The main idea here is to be able to keep up with the comprehensive list, which is gradually and consistently increasing, of diseases that are treatable or manageable, which can improve the quality of life for children, so that we can screen for them earlier.

• Speaker #0

  Because the primary objective is to prevent the possibility of the disease becoming apparent. and being treated far too late. Exactly. It's about acting as early as possible.

• Speaker #1

  For instance, the example I gave you earlier about phenylketonuria that could be detected by other means, not genetic, but biochemical methods. And now we have one truly emblematic example, is spinal muscular atrophy in infants, which can only be detected through genetics. This is a disease that was previously thought to be completely untreatable, but it is now treated by a completely revolutionary gene therapy. And it was clearly demonstrated that if this gene therapy was administered immediately after birth, the children no longer developed the symptoms of the disease, which would otherwise inevitably lead to death within the first year of life. And so from there, the idea was that these kinds of examples would become more and more common, and that it was of the utmost importance to anticipate this, and develop a reliable methodology to detect these diseases at the earliest possible stage. because once the symptoms have started, they frequently become completely irreversible.

• Speaker #0

  Okay. So in fact, we realize that these are public health issues because it's about preventing vulnerable children, families, and individuals from having to live in such difficult conditions with the disease.

• Speaker #1

  Yes. We still have to realize that it won't always be the case that we'll have exceptional situations, like phenylketonuria or infantile spinal muscular atrophy, where we will be able to stop the disease. There will be cases where we won't be able to completely prevent the onset of the disease, but in any case, we can significantly reduce the damage the disease can cause.

• Speaker #0

  Okay. Can we have some numbers? How many patients does this concern in the end in France?

• Speaker #1

  The numerical data provided in the list of pathologies that we currently want to screen for are not yet known because we have a partnership with the National Data Bank, Rare Diseases, precisely to try to identify them. As an order of magnitude, we estimate that approximately 2% of the newborns who undergo screening will be affected by one of these medical pathologies. We have this data based on international projects that have already started. There are approximately 20 different international projects currently being developed around the world, all of which we are monitoring and following very closely at this very moment. So out of these 20, not... all have started yet, but some have, particularly in China, the United States, and Australia. And in these projects, indeed, we can see that this screening, now we're not dealing with exactly the same number of diseases being screened, but we're somewhere between two and three percent, depending on the total number of pathologies screened, would be detected with this expansion of newborn screening.

• Speaker #0

  I'd like to take a brief moment right now to explain this in more general term so everyone watching can fully understand what it means. Does this mean these tests could be made available to every single person or is it based on family history, on the parents? How should we comprehend and evaluate these newborn tests?

• Speaker #1

  So these newborn tests are really offered to all newborns. Current newborn screening is offered to all newborns in this pilot phase. It will depend on the hospitals that participate. So for phase one, we're talking about five university hospitals in France. Dijon, Besson, Rennes, Nantes, and Angers. And then afterwards, the idea is to have an expansion phase at the regional level. And then eventually, depending on the results, to be able to roll it out across all of France, integrated into the standard newborn screening.

• Speaker #0

  All right. So that means these could be genetic anomalies that aren't necessarily hereditary, that can occur spontaneously. It's not necessarily related to what we're talking about.

• Speaker #1

  So regarding genetic tests nowadays, we have specialized genetic centers, like the place where I work. We receive and consult with people every day who either have genetic diseases or have a family history of genetic diseases. So offering genetic tests in these specific situations is something that has existed routinely since the very beginning. So it's an important and well-organized access when there is something. Yes, exactly. That is precisely the point. So, up until now, when we first started this discussion, we were talking about whether genetics was merely a niche interest. For quite some time indeed, genetics was almost exclusively linked to the study of rare diseases. Many people felt that it didn't concern them personally, even though in the end, genetic diseases can occur in virtually any individual at any time. Many medical conditions arise without any prior family history. And what is truly changing right now indeed is that with the arrival of modern genomics, specifically through completely revolutionary high-throughput sequencing technologies, which allow us to sequence our entire human genome, we are significantly broadening the overall scope of genetics and genomics much further than ever before, since we are now going to use these advanced tests, including, for example, two specifically tailored treatments in the field of cancer. And indeed, Given the incredible capabilities of these new technologies, we are now seriously considering actually adapting them for the purpose of disease prevention. So we are starting to talk about genetic tests for common diseases, since there may be genetic predispositions to many illnesses, such as high blood pressure, diabetes, and so on. And now for prevention programs like PERIGENOMED, currently the only project that is in the pipeline. currently in France, is focused on newborn screening because that's probably where there is the most urgency and also where we need to keep up with international competitiveness in the field. This effort aims to try to actually reduce the heavy burden of certain rare diseases that affect young children and can be extremely difficult for families to cope with. What is already being discussed at international conferences is in fact what comes next, which could potentially occur at several different stages of life. The interest in genome screening according to reproductive plans, what is commonly known as preconceptional diagnosis, which is currently not authorized by law in France, and also later on for the prevention of various other health risks.

• Speaker #0

  So to speak more concretely, When a treatment is finally put in place following a diagnosis, what exactly are the steps that take place? Once the child is born, how does the medical management actually work in practice?

• Speaker #1

  Medical treatment is implemented immediately following the moment a diagnosis of a rare disease has been confirmed. That is an essential point, really. The issue of diagnosis remains at the heart of our concerns. And then afterwards, there needs to be a treatment that actually exists. Now, as for treatment, we always have more symptomatic treatments. Support options can be offered, but treatment is intended to target the specific progression of the disease. We still have very few rare diseases that are in this situation. It is estimated that we have only about 5% of them. On the other hand, there is a very large number of therapeutic trials in this field, which really suggest the possibility of significant progress. And that is really the heart of the PERIGENOMED project. because if we had very few treatments, we wouldn't be talking about neonatal screening. So indeed, obtaining a clear answer and having a diagnosis of rare diseases very early, since with this project the idea is to provide an answer, a possible diagnosis of rare diseases within the first month of life, is something that can be viewed as being highly debatable. And that's why it is absolutely essential to have proven and effective medical treatments available, because receiving a diagnosis at only one month old, in a very early stage, right in the middle of, let's say, the establishment of the parent-child relationship, and not necessarily something that would be ideal. And so it is only acceptable if indeed we can offer family-specific treatments that will provide a meaningful difference and will effectively prevent the whole long period of diagnostic wandering.

• Speaker #0

  So the main purpose of this entire project, to be very clear, is to make a formal diagnosis. Once the child is born, or even before that, when it is still in utero, just to be perfectly clear. Does it depend significantly on the specific case?

• Speaker #1

  At this point in time, in utero, the circumstances where we can perform a genetic diagnosis are when there are ultrasound signs that strongly suggest a genetic disease. In this particular case, We also have, as a standard part of routine medical care, access to genetic analyses, including sequencing all of our individual genes, to try to reach a definitive diagnosis during pregnancy so that the parents can make a choice if it turns out to be a particularly serious condition. So if tests are done during pregnancy, if there is an ultrasound warning sign, parents may have the choice to continue or not with the pregnancy. However, we are not currently discussing a formal prevention program except for the measures that are already in place for Down syndrome within organized screening programs. We're not talking about genome sequencing for all pregnancies.

• Speaker #0

  Okay. It's clear that we're touching on a lot of highly sensitive topics. Topics related to technology, topics related to ethics, topics related to the funding of these new treatments. I would be curious to know how you approach this, how you look at and read all these. I imagine you don't necessarily have answers for everything, but how do you propose solutions?

• Speaker #1

  Since the arrival of high-throughput sequencing, let's say in France, that was the moment when we first started utilizing these genomic techniques. Back during that period, there was some hesitation and genuine concerns from a number of individuals regarding these technologies. which can also uncover various types of information that we are not specifically looking for. And so right here in Dijon, we actually set up a university hospital federation to address these complex questions. It was our colleagues who raised the truly ethical, organizational and economic questions, which made it possible to bring together many other disciplines. And that was something quite original, because before in the field of medicine, we weren't used to it. especially working with researchers in the humanities and social sciences. And we actually found experts who were interested in this particular topic who didn't necessarily know about it at first to answer all these questions. And that's really an aspect that has been fascinating throughout this journey and still is because there are still so many questions. It's about getting support and as a result learning and developing a taste for all of this. to answer these questions and develop specific projects around ETI, organizational aspects, economic factors, and so on.

• Speaker #0

  So in fact, your core business is genetics, diagnostics, looking at the science of genes. And then there are all the questions that patients, families, or even the doctors who will be treating them might have.

• Speaker #1

  Exactly. And our society, our various supervisory bodies, and so on. Because It is certainly true that in the aftermath it raises real questions about knowing what we need to implement in routine care, how, at what cost, and what important choices to make.

• Speaker #0

  And how do you start to answer these questions? What are the guidelines you're following right now?

• Speaker #1

  So from an ethical standpoint, if we're talking about genomics in general, it's very much about the issue of what we call incidental findings. So everything we can learn, everything we might stumble upon, let's say. when sequencing the genome for, for example, diagnosing rare diseases, and which could provide information about genetic predisposition to cancer, to cardiac arrhythmias, and which was not the question the individuals were seeking answers to. And it's true that this is something that is a huge debate in France, which is not necessarily shared everywhere internationally. In the United States, for example, it's considered an opportunity because it allows for prevention. And in France, there is a significant and growing social movement that believes we are indeed providing information that people did not necessarily wish to receive in the first place. Even if there is formal consent, the idea is that by asking them the question, they might feel they do not truly possess the genuine freedom or choice to say no, even though in reality, the vast majority of French citizens and residents, whether living in France or elsewhere, do ultimately consent to receiving this information. So this is truly the primary debate in routine care. And then regarding newborn screening, which we touched on just a little bit earlier, it's really about we are looking to see whether it. those families who have already received a result will be satisfied to have gotten an earlier result than they expected. Because it's difficult to understand for the consent phase for individuals. It's complicated, as we can see, to understand all these aspects. So we know that the way people choose to respond to different situations is not always necessarily measured, which essentially means that people won't necessarily realize you the consequences of the potential consequences. There are so many diseases that we can't explain them all, and in some cases they might even think that they would have preferred to receive a diagnosis later. So that's an important point, and then there's another point, a bit related, which is that while these technologies are precise, we still can't interpret everything perfectly. And there's a small risk that we might raise an unnecessary alarm. This already happens in standard neonatal screening, that we might alert people about a potential rare disease that ultimately won't be confirmed later.

• Speaker #0

  So as a result, these are debates, ongoing discussions, right?

• Speaker #1

  Yes, and that's what we need to demonstrate with the pilots. So it's in the pilot projects that we've been able to launch within our University Hospital Federation that we'll address this. We have questions, we have a very solid rationale. several serious concerns have been raised, technical questions as well and broader economic questions. We're going to implement a pilot project to address them.

• Speaker #0

  And so I guess technology too has a role to play in being more precise or help to better answer these questions?

• Speaker #1

  Yes, so on that point, the international community plays a big role. What we will learn from interpreting variants is a huge challenge, that's for sure. artificial intelligence also comes into play. And everyone needs to contribute so that our understanding of pathological and non-pathological variants increases because we each have, in the coding regions of our genes, about 20,000 differences from one another. If we even consider the genome and the non-coding regions, there are actually significantly more than that. We estimate there are approximately 3 billion base pairs, and that means that within our entire genetic code, Finding the right variations that will explain the pathology is a complex and difficult challenge. So we have classifications of variations that can be mutations classified as pathogenic. In those cases, we can be confident, so to speak. Then others are likely pathogenic with minor error risk. Next, there are many uncertain significance variants, and we have a lot of those. And then after that, there are probably benign or benign variants. we are not able to interpret all the variants and classify them all properly as we should. We have many variants of uncertain significance and variants that are probably pathogenic or that we think are... So currently in France we have a France Genomic Medicine Plan. This system includes two genome analysis platforms which are open access and to which we send our genome analyses when we see a patient at a genetic center in France and these platforms are effectively equipped with software that helps with variant classification and diagnosis. And it's true that very often the diagnosis retained is among the medical diagnoses, ranked as first line by the software.

• Speaker #0

  And just to be clear, that means you will carry out an initial comprehensive phase of the project based on the extensive preliminary research and data collection you have already done. That means it aligns perfectly and integrates seamlessly into what is essentially a broader strategic framework of our national health policy.

• Speaker #1

  Yes, and in any case, the PERIGENOMED project is considered the national pilot project. It focuses on this issue with a genuine federation of all stakeholders involved in genomic medicine. It is truly a comprehensive project that was carefully designed and developed. in close collaboration with all the key stakeholders across France involved in newborn screening, healthcare networks, rare diseases, genomic medicine, patient associations and many other essential partners. The current idea we have is to effectively be able to, at this stage, move forward with the pilot deployment project to see if it is feasible on a larger scale because this first phase will take place at the university hospitals, CHUs. University hospitals, CHUs, are used to conducting research and we need to see how this could be integrated in terms of information into all the maternity wards. Because in this first phase, there will be people present to inform couples, spending about 20 minutes with them to explain the project and to obtain their consent. And this is probably something that will be impossible to maintain in all the maternity wards in France. So this second phase will need to be more, let's say, integrated into the real world of screening. And as a result, it's a real challenge with all the aspects that will also need to be demonstrated, including the cost of all this. There you have it. The technical, organizational and economic feasibility, which is the challenge of this second phase.

• Speaker #0

  We can see it's a mix between partly a driver of innovation and public health issues. There is also perhaps a wave, a momentum, which is linked to an explosion of technology or Maybe it's something you're seeing at the international level that there's a train to catch now?

• Speaker #1

  Yes, that is exactly it. So this train to catch, we've actually been feeling it for quite some time now around newborn screening within our Federation University Hospital. In 2019, we started to talk about it. The fact that the next pilot project to be implemented would be focused on neonatal screening. But I would say that at the time we didn't. We didn't yet have that example we talked about earlier of infantile spinal muscular atrophy. And the critical importance of very early diagnosis to change the progression of the disease. And that's why at that time it wasn't really feasible to set up a pilot project. And so we did the opposite of what we usually do. We started by setting up a humanities and social sciences project to study the acceptability among professionals and the general population. especially couples of childbearing age or those who had just had a child, to see what their expectations were. And the acceptability was good, very good. We're at approximately 80 to 86% between professionals and couples. And at the same time, there were indeed notable advances at the international level, where we saw pilot projects being set up. And in parallel, as a result of this acceptability project called SEDEN, We thought that it was indeed the right moment.

• Speaker #0

  Well, I would really like to take a moment to do a very quick and thorough review of your work as a researcher. What would you like to say after all the lessons you've seen and for young researchers who want to follow in your footsteps?

• Speaker #1

  Well, I think first of all you have to keep following your convictions. I think that when you are convinced, you know how to convince others. Another key point. is to be surrounded by a strong, capable team that truly supports you. You can't do anything alone. Having a fully committed and reliable team, having a team that can respond quickly to our needs, because obviously we're not specialists or experts in every aspect, so you really need people who can cover a wide range of different areas effectively. And then you also need to know how to identify the necessary funding. Because if you don't have the funding to see things through, you will eventually find yourself blocked at some point. So I definitely think those are the main key points.

• Speaker #0

  If I may ask, have you ever thought that it might actually be easier for me to go work in the United States as a researcher there?

• Speaker #1

  The thing is, before being a researcher, I consider myself above all a clinical physician. And being a clinical physician in the United States isn't easy because there is no equivalency. So you can do it in other parts of Europe, but not in the United States. So you can be a researcher in the United States, but you can't just do consultations. Then in the United States, there are obviously advantages and disadvantages as well. Furthermore, we maintain a steadfast commitment to a policy of excellence. which is a heavy burden to bear, even if we set a policy of excellence for ourselves. It's not imposed by others. And having a policy of excellence imposed on you is complicated.

• Speaker #0

  We've had researchers sometimes who were at top universities and who weren't kept on at some point because they had a slight dip in their performance at some point in their lives. In France, we can live with that in our institutions. And in the United States, that's something that's not possible. So you have to weigh the pros and cons.

• Speaker #1

  Did you ever ask yourself that question at some point?

• Speaker #0

  Well, I would say yes and no. It's hard to explain. It's quite a complex subject, let's say.

• Speaker #1

  Yes, it's a complex subject. Especially in a field like this, in genetics, a lot more things happen. Or in other countries. Obviously, you looked at things differently.

• Speaker #0

  We were really lucky within our institution, really. That is to say, from the very beginning, we have been strongly supported in our genomics projects. Rare diseases have been a recognized research focus from the start within our institution. And that's something to take into account. That is, we can also clearly see what is happening elsewhere. Rare diseases are not always as well regarded in other institutions. And so I am not entirely convinced that when you are in such a positive dynamic, working closely together with our directors and deans, you would really feel the need to look elsewhere just to see if things are going well.

• Speaker #1

  I'd like to chat a bit about what the future of genomics might look like, I don't know, in five or ten years. In your opinion, how is it going to take shape? What is going to be put in place? How is it going to be organized?

• Speaker #0

  It's almost easier to answer for 20 years out, because five to ten years isn't actually that long. It is certainly true that discussions around prevention are of very great importance at this current moment within the international community. with the significant potential role of genome sequencing for proactive preventive healthcare purposes at different ages and stages of life. This is something that will surely be feasible because now a genome analysis is something we can obtain with new technologies. Around 200 to 250 euros with the new machines, not all of them of course, but this means it will be able to have a real place. probably with the improvement of our knowledge. So the possibility of having tests for preventive purposes is going to be a bit of the challenge for research in the coming years.

• Speaker #1

  This means that not only for you, what is newborn will inevitably happen and will be the first step, and then it's prevention measures at all ages of life for a wide range of more common pathologies.

• Speaker #0

  So I honestly would not be able to tell you. if this will inevitably occur for newborn screening programs, because the financial stakes are enormous. Right now, with standard newborn screening, we're only talking about a few dozen euros. If we were ever to integrate genomics into newborn screening, the cost would immediately jump to several hundred euros per newborn. And will France decide to embark on this policy or not, compared to other choices?

• Speaker #1

  Because that's the real issue.

• Speaker #0

  There will be this and then everything else. Healthcare is evolving and advances in health are happening everywhere. And there are various other screenings like those for cancers and others, which are still highly valued and respected in France. So will France already decide to fund a second phase? The answer is we simply don't know that yet at this moment. And then as for the decision to fund a full-scale rollout. that's something I don't have the answer to right now. Of course, that's exactly what we hope for if our pilot projects yield encouraging and positive results. Because if we are running pilot projects, it's really because there are questions that need to be answered and to see with the international community. A very real and significant point of discussion that is now starting to emerge among those working on more advanced projects. is whether we will actually be able to offer a comprehensive model that can be proposed to everyone. This is a major concern because what we see is that many different states won't necessarily be ready or willing to finance all of this extensive work on their own. And the potential danger, which is not generally the policy in France, is that these things might be made available exclusively to certain people who are able to afford these technological breakthroughs. and not to others.

• Speaker #1

  So if you prefer, go to different countries.

• Speaker #0

  So, for example, there are genetic tests that exist for preconception purposes, which are currently prohibited in France but are accessible in other nearby French-speaking countries. Nevertheless, very few people take advantage of them. They go to do these tests elsewhere, probably due to a lack of awareness as well. That is to say, when it comes to genetics, especially rare diseases, there is really this sense that it affects others and not me.

• Speaker #1

  In your opinion, what is the role of pharmaceutical companies in this developing ecosystem?

• Speaker #0

  Pharmaceutical companies play an incredibly vital role because, quite frankly, the comprehensive distribution and rollout of innovative medical treatments is largely in their hands. Furthermore, there have consistently been very high expectations placed upon these companies to provide substantial support for these critical newborn screening expansion projects. But for now they are not the ones who have decided to primarily fund these projects. However, they are more than welcome to help with co-financing as much as they possibly can. because I truly believe that we all stand to benefit immensely from seeing these projects reach their successful fruition.

• Speaker #1

  Okay, for you actually, if I understand correctly, this is a first step towards gaining a much deeper understanding of the things regarding these significant large-scale developments in genomic prevention?

• Speaker #0

  to be able to administer it to people who have very few symptoms or perhaps none at all, so that symptoms don't develop. And that's where I think pharmaceutical companies have really, should truly be a vital and core part of this medical journey. Because through newborn screening, we will be able to demonstrate that these treatments, when they are given as early as possible, are the most effective and beneficial for patients. Of course. we're often dealing with diseases that are very rare, which means that our pilot project, in phase two we're talking about roughly 20,000 newborns, and when we're dealing with a condition that affects one newborn out of 200,000, the natural reaction is indeed that the probability is you won't detect any cases of my condition. And so that's where I would say the international community comes in, because there is a real coming together of pilot projects internationally within a consensus called ICONS, which I would say altogether will allow us to actually detect certain conditions and not others. And I think we really need to see it as a fantastic network to fully demonstrate all of this.

• Speaker #1

  Okay. Thank you very much. This episode was truly fascinating as it helps us to better understand how the field of genomics is rapidly moving from a niche area of study to perhaps it is the very beginning of tomorrow's preventative medicine and future prevention. In this silent competition, timing matters. If the United States takes more risks, if China moves faster, can Europe afford to be cautious? In the next episode, we move from genomics to artificial intelligence. as AI is booming on a global scale. But even when research is excellent, access sometimes remains limited. And following this episode, I have a question for you. Should Europe prioritize ethical caution or speed up to stay competitive?